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U.S. to Buy German Flu Vaccine

Report on Obtaining Cheaper Drugs Abroad to Miss Deadline

By Ceci Connolly

Washington Post Staff Writer
Wednesday, December 8, 2004; Page A02

The Bush administration said yesterday that it intends to purchase 1.2 million doses of flu vaccine from a plant in Germany to ease this year's shortage. At the same time, health officials said they will miss today's deadline for reporting to Congress on the hot-button question of whether Americans should be allowed to buy lower-priced prescription drugs from countries such as Germany and Canada.

Although administration officials contend that the two are distinct matters, the juxtaposition of the announcements sparked swift and harsh criticism from elected leaders in both parties who accused the White House of hypocrisy.

Q. What is the flu? A. A viral respiratory infection. Symptoms include headaches, dry cough, muscle aches and fatigue, and possible congestion, sore throat and fever.Q. How do you treat the flu? A. Rest, drink plenty of fluids and avoid alcohol and tobacco. Since the flu is a virus, antibiotics can't cure it.Q. Who should get a flu vaccine? A. People older than 65, children 6 to 23 months old, pregnant women and adults or children with chronic health conditions are at greater risk for severe illness.  From The Post: Flu Q & A

"Here we are buying flu vaccine from Germany and yet they're sitting on a report that probably says it is dangerous to purchase medicines from other countries," said Rep. Gil Gutknecht (R-Minn.). "Why is it that the FDA [Food and Drug Administration] can do this safely but your local pharmacist can't?"

Sen. Byron L. Dorgan (D-N.D.), who had briefly held up the Senate confirmation of Mark B. McClellan to run the Medicare program last spring, threatened to use the tactic again to block the confirmation of the next secretary of the Department of Health and Human Services. The current secretary, Tommy G. Thompson, has announced his resignation, effective in early 2005.

Dorgan said the only reason he lifted his "hold" on McClellan then was that Senate Majority Leader Bill Frist (R-Tenn.) had promised a Senate vote on legislation to legalize drug imports, also called "reimportation" because many pharmaceuticals are made in the United States.

"I felt Senator Frist had given me assurances we would have our vote on reimportation," Dorgan said in an interview. "I'm not likely to make the same mistake twice. I intend to use all the leverage I can to get this vote."

Frustration over the rising cost of prescriptions has spread from individuals to mayors, governors and lawmakers. In the Medicare drug law passed a year ago, Congress required Thompson to file a report on importation by today. For months, he promised it would be completed before Labor Day. But yesterday, Thompson said he will be traveling overseas and will not be able to review the document until he returns.

"We'll get it there very shortly," he said.

In defiance of the FDA, several states have created programs steering Americans to the Web sites of Canadian and European pharmacies that they deem safe and reliable. This week, the American Medical Association endorsed the importation of drugs as long as the medications have electronic tracking devices to protect against counterfeits.

Vermont Gov. Jim Douglas, a Republican, has sued the Bush administration in federal district court asking the FDA to write regulations for legal importation. AARP, the nation's largest lobbying group for people 50 and older, has said that it will file a brief to support the lawsuit, according to Assistant Attorney General Mike McShane of Vermont.

Several lawmakers said the flu-vaccine decision is not the first time the Bush administration has turned to Europe for emergency medical supplies. In 2001, Thompson arranged the purchase of the antibiotic ciprofloxacin from Europe during the anthrax attacks.

"It's ironic the U.S. government wants to deny consumers the right to access international markets when in fact that's exactly what the federal government does when it needs Cipro or flu vaccine," Rep. Rahm Emanuel (D-Ill.) said.

Health officials have been scrambling to locate flu vaccine since the October announcement by California-based Chiron Corp. that, because of bacterial contamination at its Liverpool plant, it could not ship 48 million doses intended for the United States.

Several cities and states, led by Illinois, found 750,000 available doses in other countries and asked the FDA for approval to purchase the vaccine. That decision is pending. New Mexico Gov. Bill Richardson (D) said the HHS purchase, "while welcome, is late and costly. The state is going to keep its options open for acquiring new supplies of vaccine, including its relationship with Illinois."

Because the German-made vaccine is not licensed in the United States, patients will be required to sign a consent form before they can receive it. Thompson stressed, however, that the vaccine made by GlaxoSmithKline has been licensed in Europe and is used in 30 countries.

The 1.2 million doses will cost taxpayers at least $8.4 million, and patients will likely pay $15 to $20 in administrative costs for a shot. Because of those complexities, the Glaxo batch will be used as a last resort, said Mitch Cohen, a flu expert at the Centers for Disease Control and Prevention. "We still have licensed vaccine available, and it is certainly simpler to use the licensed vaccine first," he said.

The vaccine crisis has hit some states particularly hard, while others have excess supplies. Kris Ehresmann, director of the Minnesota immunization program, sent 3,000 spare doses to Maryland yesterday and expects to release a total of 30,000 doses.